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Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry

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Navigating Pharmacogenomic Testing in Practice: Who to Test and When to Test.

James M Stevenson^1,2, D Max Smith^3,4, Sony Tuteja⁵

¹Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Clinical Pharmacology and Therapeutics

|May 6, 2025

Summary

This summary is machine-generated.

Pharmacogenetic (PGx) testing offers personalized medication management but faces adoption barriers due to inconsistent guidelines and unclear patient selection criteria. This review explores factors influencing PGx testing decisions and models for implementation.

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Area of Science:

Pharmacogenomics
Clinical Pharmacology
Personalized Medicine

Background:

Increasing interest in pharmacogenetic (PGx) testing for individualized medication management.
Limited routine PGx testing recommendations in clinical practice guidelines, hindering adoption.
Inconsistencies in guidelines, FDA labeling, and reimbursement policies impede widespread use.

Purpose of the Study:

To discuss critical considerations for determining who should receive PGx testing and when.
To explore factors beyond clinical validity, including actionable result frequency and alternative treatments.
To present perspectives on identifying PGx testing candidates in real-world clinical settings.

Main Methods:

Review of existing resources and clinical practice guidelines related to PGx testing.
Discussion of various considerations for PGx testing candidate selection.
Analysis of different PGx testing models: preemptive, pretreatment, and reactive testing.

Main Results:

Multiple factors influence PGx testing decisions, including clinical validity, actionable result frequency, adverse outcome severity, predictive power, alternative treatments, cost, and turnaround time.
Existing resources often lack guidance on patient selection for PGx testing.
Different testing models (preemptive, pretreatment, reactive) have distinct advantages and disadvantages.

Conclusions:

Addressing the question of 'who' and 'when' for PGx testing is crucial for clinical adoption.
A comprehensive approach considering multiple factors beyond drug-gene interactions is necessary.
Real-world candidate identification for PGx testing requires careful consideration of practical and clinical factors.